V-PRO® Low Temperature Sterilization SystemEnvironmental H202 Safety Profile

V-PRO® Sterilizer Environmental H2O2 Safety Testing
No matter where you work, we all expect to go home at the end of each day safe andsound. At STERIS, we believe this is of the utmost importance for our Customers andemployees. Safety is our most important activity at work, whether in sterile processing,
manufacturing or servicing equipment, and with over 124 years of practice, STERIS is aworld class expert on safety with the record to prove it.
Sterile processing department (SPD) managers are required to be knowledgeable on avast array of standards. With something as important as employee safety, it isimperative to seek out current government standards, occupational healthorganizations, certified industrial hygiene experts or other similarly educatedprofessionals for guidance and support. This is a summary of how STERIS uses theseresources when testing the safety of the V-PRO® Sterilizers, and the results, which
validate the environmental safety of the V-PRO Sterilizers for healthcare employees.
BackgroundTo protect healthcare employees, the Occupational Safety and Health Administration(OSHA) has established a Permissible Exposure Limit (PEL) for hydrogen peroxide
exposure of 1 ppm over an 8-hour Time Weighted Average (TWA). For many
departments, an 8-hour TWA correlates to the exposure an employee may encounter
during an 8-hour shift. A different evaluation for transient exposures is the short-term
exposure limit (STEL), which is the maximum amount of a chemical that an employee
can safely be exposed to over a 15-minute period. Where established, this short-term
limit can ensure that large chemical exposure is not minimized when averaged over 8hours. While STELs exist for many chemicals, OSHA has not established a STEL forhydrogen peroxide. In countries outside the United States, different occupational healthorganizations have established their own PELs and STELs for hydrogen peroxide. See
Table 1 for a few examples.

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Environmental H202 Safety Profile

Table 1. Examples of Global Hydrogen Peroxide Exposure Limits
Country

PEL 8-hour
TWA (ppm)

STEL/ 15-min
TWA (ppm)

ReferenceUSA1Not establishedOSHA, 29 CFR 1910.1000, Table Z-1Australia

1

Not established

Safe Work Australia, Workplace-exposurestandards-airborne-contaminants, 2013

France1

Not established

INRS, H2O2 Base de données FICHESTOXICOLOGIQUES, 2016

Germany

0.5

0.5

MAK-Werte Liste, 2012

Mexico12

NORMA Oficial Mexicana NOM-010-STPS-1999

Poland1.5

4Ministra Pracy I Polityki Społecznej, 2005

Spain

1

Not establishedUK

12

INSHT LÍMITES DE EXPOSICIÓN
PROFESIONAL PARA AGENTES QUÍMICOSEN ESPAÑA, 2008
HSE EH40, 2011

Test Methodology
Since OSHA is the organization responsible for workplace safety standards in theUnited States, the hydrogen peroxide monitoring was conducted in accordance with thefully validated OSHA test method, 10192. An independent industrial hygienist (CertifiedIndustrial Hygienist and Certified Safety Professional) conducted the testing inaccordance with practices outlined in 21 CFR § 58 Good Laboratory Practices (GLP) for
Non Clinical Laboratory Studiesi. The V-PRO Sterilizers used for the testing wereinstalled and maintained according to STERIS’s recommendations.

M4496ENV-PRO® Low Temperature Sterilization System
Environmental H202 Safety Profile

There are two approaches for monitoring workers’ chemical exposure in the workplace:••Employee breathing zone measurements, which are critical as they evaluate the actual
exposure for the employee.
Monitoring the area near chemical source, which may identify unsafe levels prior to anexposure.

STERIS included both approaches in this testing.
In accordance with the OSHA method 1019, a calibrated pump was used to draw air across acoated filter. The measurements were collected at three (3) locations: above the door of the VPRO maX Sterilizer (Figure 1), above the door of the V-PRO 60 Sterilizer (Figure 2), and in theemployee’s breathing zone (Figure 3). On each sterilizer, the filters used to collect the samples(for both the PEL and 15-minute exposure) were placed directly above the sterilizer door, flushwith the front of the sterilizer.

Figure 1: V-PRO maX Sterilizer with filters

Figure 1: V-PRO 60 Sterilizer with filters

On the employee, the devices used to collect the samples (for both PEL and 15-minuteexposure) were placed within the employee’s breathing zone.

Figure 2: Employee with filters in breathing zoneM4496EN

V-PRO® Low Temperature Sterilization System
Environmental H202 Safety Profile

How the Testing was Performed
The two sterilizers processed loads continuously during the test, as is typical in many sterile
processing departments. The Non Lumen Cycle for both the V-PRO maX and V-PRO 60
Sterilizers was used since it is the shortest duration cycle (28 minutes), and therefore createdthe most potential exposures during a workday. Use of other longer V-PRO Sterilizer cycles
would reduce the number of times the employee approached the sterilizer and would reduce theexposure to the chemical source. The 2-sterilizer, shortest cycle method creates a realistic but
challenging scenario to evaluate environmental employee safety.
Samples were collected for the PEL evaluation (which included loading, unloading and in-cycle
processing time for the sterilizers) as the sterilizers continuously processed loads. Within thesame test period, two separate 15-minute exposure samples were collected for each sterilizer
individually as well as for the employee operating both sterilizers.
The employee 15-minute evaluations were coordinated to align with the time that, for bothsterilizers, the employee unloaded the sterilizer at the end of cycle, transported the load, andplaced a new load into the sterilizer. This method maximized the number of times there wasinteraction with the sterilizers during the 15-minute periods, making this an ideal test to evaluate
the employee’s short term exposure.
In addition, loads consisted of double-wrapped sterilization trays for which all materials werelabelled for use in V-PRO Sterilizers. All cycles completed normally during the test.

All samples were analyzed by an accredited Industrial Hygiene laboratory in accordancewith the OSHA test method 1019.
Results
Breathing zone measurements are the most relevant to understand employee safety asthese measurements evaluate actual employee exposure. Measurements taken at
the breathing zone of the employee and above both sterilizers were below theOSHA PEL of 1 ppm over an 8-hour TWA as well as below PELs establishedoutside the United States (Table 1). Note that the employee exposure (Table 2) whileloading, unloading and operating two sterilizers is less than the sum of the two sterilizer
measurements.

M4496ENV-PRO® Low Temperature Sterilization System
Environmental H202 Safety Profile

Table 2. Test ResultsCollection Site8-hour TWA(ppm)

V-PRO maX Sterilizer
V-PRO 60 Sterilizer
Employee Breathing Zone

0.26
0.11
0.12

15-min TWA (ppm)
#1
#2
0.43
*
*

0.40
0.23
*

* Less than the analytical test method detection limit.

There is no OSHA short term exposure limit (STEL) for hydrogen peroxide; however
occupational health organizations outside the United States (Table 1) have established
STELs for hydrogen peroxide. The employee breathing zone results for the 15minute exposures evaluated in this testing are less than the test detection limit
and are all below STEL limits set outside the United States.
The American Conference of Governmental Industrial Hygienists (ACGIH®) is amember-based organization that advances occupational and environmental health, toinclude publication of annual editions of the TLVs® and BEIs® book. TLVs® and BEIs®
are not standards, but provide guidelines for those trained in the practice of industrialhygiene. With regards to short term exposure limits, ACGIH suggests that:Transient increases in workers’ exposure levels may exceed 3 times thevalue of the TLV-TWA level for no more than 15 minutes at a time, on nomore than 4 occasions spaced 1 hour apart during a workday, and under nocircumstances should they exceed 5 times the value of the TLV-TWA level.
In addition, the 8-hour TWA is not to be exceeded for an 8-hour work period.
This guidance on limiting peak exposures above the value of the TLV-TWA isanalogous to that for the TLV-STEL, and both represent 15-minute exposurelimits.3
Test results from 15-minute exposure monitoring in Table 2, which takes into accountthe air volume, sampling time, and sampling rate requirements of OSHA occupational
monitoring, are well beneath actionable levels recommended by the ACGIH to industrial
hygiene professionals (5 x 1ppm = 5ppm as a 15-minute TWA). Therefore, testing inaccordance with the OSHA test method supports the overall safety of V-PRO Sterilizers.

M4496ENV-PRO® Low Temperature Sterilization System
Environmental H202 Safety ProfileConclusions
This testing demonstrates that the V-PRO Sterilizers are safe for healthcare employees
and the environment. Hydrogen peroxide emissions from the V-PRO Sterilizer process
are well below the OSHA established PEL for hydrogen peroxide (1 ppm 8-hour TWA).
The 15-minute exposure monitoring of the V-PRO Sterilizers further demonstrates thesafety of these units for the workplace environment.
When performing independent environmental testing, STERIS recommends following avalidated protocol such as the OSHA test method 1019 with the guidance of anindustrial hygienist or other qualified personnel with experience evaluating such testsystems. If using another test method to evaluate environmental emissions, a clear
understanding of the monitor characteristics (which may include response time,accuracy, precision, etc.) and the impact of those characteristics on the observed
values is needed to correctly interpret the data and understand how the monitor results
relate to employee safety.
References
1. OSHA Occupational Safety and Health Standards, 29 CFR 1910.1000, TABLE Z1 Limits for Air Contaminants
2. OSHA Test Method 1019 for Hydrogen Peroxide, version 1, January 2016
https://www.osha.gov/dts/sltc/methods/validated/1019/1019.pdf
3. ACGIH 2016 TLVs® and BEIs®, ISBN 978-1-607260-84-4
Disclosures and Acknowledgements
The industrial hygienist used in this study was paid a fee for the work performed. No additional
compensation was provided for participation in this testing and neither the industrial hygienist nor theassociated company has a vested financial interest in STERIS or its subsidiaries.

iCompliance was not mandatory since the testing was not subject to a review and did not require Part 58
compliance. The best practices outlined were followed to help ensure the quality and integrity of the data.

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